AstraZeneca, Rigel Enter RA Development Pact

AstraZeneca and Rigel Pharmaceuticals entered an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel’s late-stage investigational drug for rheumatoid arthritis (RA) and additional indications. Fostamatinib disodium has recently completed a comprehensive Phase II program.

AZ will make an upfront payment to Rigel of $100 million, with as much as an additional $345 million based on development, regulatory, and sales milestones. Rigel will also be eligible to receive as much as an additional $800 million of specified sales related milestone payments, as well as royalties on worldwide sales. AZ is responsible for all development, regulatory filings, manufacturing and global commercialization activities.

AZ will design a global Phase III program, which is expected to begin in 2H10, with the goal of filing new drug applications with the FDA and EMEA in 2013. Under the terms of the agreement, AZ will also receive exclusive rights to Rigel’s portfolio of oral Syk inhibitors, as well as additional indications for fostamatinib disodium.

Anders Ekblom, executive vice president of development, of AstraZeneca said, “There is a very real and pressing unmet medical need in the area of rheumatoid arthritis. Given the debilitating effect this disease can have on patients, AstraZeneca looks forward to working together with Rigel to continue development of this innovative investigational compound. Collaborations such as this one, which further strengthen our late-stage pipeline, demonstrate the key role externalization continues to play in AstraZeneca’s strategy.”

James M. Gower, chairman and chief executive officer of Rigel Pharmaceuticals, Inc. said, “This collaboration fulfills our expectations in two key ways. First, AstraZeneca has made an expansive commitment to develop fostamatinib disodium for the treatment of RA, which means that the work we have begun for patients with this disease will be completed with a substantially larger clinical program. Second, Rigel will receive royalties on potential future sales, appropriate to its investment in the development of R788.”